Pharmacokinetics of Carbapenem Antibiotics in Obese Patients.

University of Ulm13 enrolled

Overview

Tissue kinetics of ertapenem and meropenem in fatty tissue, intraperitoneal fluid and plasma.

The purpose of this study is to determine the free tissue kinetics of ertapenem and meropenem in fatty tissue and intraperitoneal fluid up to 24 hours after administration of the IMP.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

microdialysis catheterPROCEDURE

Placing of microdialysis catheter in fatty tissue and in the peritoneal cavity

microdialysis catheterPROCEDURE

Placing of microdialysis catheter in fatty tissue and in the peritoneal cavity

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at intraabdominal organs * BMI more or even 40 * written informed consent Exclusion Criteria: * BMI \< 40 * pregnancy or lactation in women * emergency surgery * history of serious allergy or intolerance to β-lactam antibiotics * systemic antimicrobial therapy with ceftazidime (internal standard of high-performance liquid chromatography / mass spectrometry) within a 7 days period prior to study entry * ongoing intraabdominal infections * terminal illness * severe diseases of the liver, e.g. cirrhosis of the liver with ALT or AST \> 6 x upper limit of normal (ULN) and bilirubin \> 3 x ULN * severe renal insufficiency with a creatinine clearance ≤30 mL/min. * neutrophil count \< 1000 cells/mm3 * platelets \< 75000 cells/mm3 * coagulation studies (INR) \> 1.5 x ULN * ongoing chemotherapy and/or radiotherapy * ongoing therapy with valproin acid (in case of ertapenem administration).

Locations (2)

University of Ulm, Dept. of Visceral Surgery

Ulm, Germany

University of Ulm

Ulm, Germany

Outcomes

Primary Outcomes

Unbound concentration of ertapenem and meropenem in fatty tissue and peritoneal fluid

Time frame: within 24 h after administration

Secondary Outcomes

Number of Adverse Events (total and per patient)

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Number of Serious Adverse Events (total and per patient)

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Number of Suspected Unexpected Serious Adverse Reactions (SUSARs)

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Data from ClinicalTrials.gov

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